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Weight-bearing Radiographs to Evaluate Stability in Ankles With Isolated Weber Type B Fractures.

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ClinicalTrials.gov Identifier: NCT03831009
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ostfold Hospital Trust

Tracking Information
First Submitted Date  ICMJE February 4, 2019
First Posted Date  ICMJE February 5, 2019
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
The Manchester-Oxford Foot Questionnaire (MOxFQ) [ Time Frame: 24 months ]
Ankle/foot specific patient-reported outcome measure
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03831009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • Olerud-Molander Ankle Score (OMAS) [ Time Frame: 24 months ]
    Ankle/foot specific patient-reported outcome measure. Maximum score (100) = best. Minimum score = 0 (worst). Poor = 0-30, Fair = 31-60, Good = 61-90, Excellent = 91-100. Presented as total score (0-100).
  • AOFAS ankle-hindfoot [ Time Frame: 24 months ]
    Ankle/foot specific patient-reported outcome measure
  • VAS/NRS of pain [ Time Frame: 24 months ]
    Visual analogue pain scale - patient reported. Scale 0-10. 10 = worst possible pain, 0 = no pain
  • Eq-5d [ Time Frame: 24 months ]
    Genereic health related quality of life patient reported outcome measure
  • Fracture healing [ Time Frame: 24 months ]
    Radiographic result
  • Registration of complications [ Time Frame: 24 months ]
    Yes/No for malalignment, deep vein trobosis, nerve injury, wound infection, delayed wound healing and crossover to surgery (including reason for crossover).
  • Bilateral ankle range-of-motion [ Time Frame: 24 months ]
    Measured in degrees with a goniometer ad modum Lindsjö.
  • Bilateral calf circumference [ Time Frame: 24 months ]
    Calf circumference in centimeters measured 10 cm distal to the tibial tubercle Calf circumference in centimeters measured 10 cm distal to the tibial tubercle using measuring tape
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Olerud-Molander Ankle Score (OMAS) [ Time Frame: 24 months ]
    Ankle/foot specific patient-reported outcome measure
  • AOFAS ankle-hindfoot [ Time Frame: 24 months ]
    Ankle/foot specific patient-reported outcome measure
  • VAS/NRS of pain [ Time Frame: 24 months ]
    Visual analogue pain scale - patient reported
  • Eq-5d [ Time Frame: 24 months ]
    Genereic health related quality of life patient reported outcome measure
  • Fracture healing [ Time Frame: 24 months ]
    Radiographic result
  • Registration of complications [ Time Frame: 24 months ]
    Yes/No for malalignment, deep vein trobosis, nerve injury, wound infection, delayed wound healing and crossover to surgery (including reason for crossover).
  • Bilateral ankle range-of-motion [ Time Frame: 24 months ]
    Measured in degrees with a goniometer ad modum Lindsjö.
  • Bilateral calf circumference [ Time Frame: 24 months ]
    Calf circumference in centimeters measured 10 cm distal to the tibial tubercle Calf circumference in centimeters measured 10 cm distal to the tibial tubercle using measuring tape
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weight-bearing Radiographs to Evaluate Stability in Ankles With Isolated Weber Type B Fractures.
Official Title  ICMJE Weight-bearing Radiographs to Evaluate Stability in Ankles With Isolated Trans-syndesmotic Lateral Malleolar (Weber Type B) Fractures. A Pilot Study.
Brief Summary The investigators will conduct a prospective cohort study on the use of weight-bearing radiographs to evaluate stability in ankles with isolated, trans-syndesmotic (Weber type B) fibular fractures. Stable fractures will be treated conservatively using a functional brace, unstable fractures will undergo surgical fixation.
Detailed Description

It is widely accepted that fractures in stable ankles can be treated non-operatively and fractures in unstable ankles needs internal fixation surgery (Michelson, Magid & McHale, 2007, Gougoulias, Khanna, Seellariou, Maffulli, 2010). Clinical decision-making is thus based on ankle stability evaluation. The integrity of medial structures, mainly the deep deltoid ligament, is considered the most important determinant for stability of the ankle mortise (Michelson, Magid & McHale, 2007, Gougoulias, Khanna, Seellariou, Maffulli, 2010). Weber B fractures, with no obvious sign of medial side injury on initial plain radiographs, have to be considered of uncertain stability until adequate stress testing is performed.

Currently there is no definite consensus on what test(s) best determines stability in ankles with undisplaced, isolated lateral malleolar fractures. Much used methods comprises manual stress radiographs and gravity stress radiographs (McConnel, Creevy & Tornetta, 2004). However recent studies have shown that such methods overestimate the need for surgical fixation indicating the need for a different method to make up the basis for surgical indication (Dawe, Shafafy, Quayle, Gougoulias, Wee & Sakellariou, 2015, Hastie, Akhtar, Butt, Baumann & Barrie, 2015, Holmes, Acker, Murphy, McKinney, Kadakia & Irwin, 2016, Hoshino, Nomoto, Norheim & Harris, 2012, Koval, Egol, Cheung, Goodwin & Spratt (2007), Seidel et al., 2017, Weber, Burmeister, Flueckiger & Krause, 2010). Authors of recent studies have proposed weightbearing radiographs as an alternative method to distinguish stable and unstable fractures, significantly reducing the need for operative treatment (Dawe et al., 2015, Hastie et al., 2015, Hoshino et al, 2012, Holmes et al., 2016, Seidel et al., 2017, Weber et al. 2010).

To evaluate weight-bearing radiographs ability to determine stability our primary focus is to evaluate if conservative treatment for "gravity unstable/weightbearing stable" ankles produces different outcomes than conservative treatment for "gravity stable/weightbearing stable" ankles.

Participants will be assigned to non-operative or surgical treatment based on ankle stability evaluation using results from weightbearing radiographs consistently. Stable ankles will be treated non-operatively with a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises. Standard operative treatment is open reduction and internal fixation of the fracture using plate and screws.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two-arm parallel assignment. Based on stability evaluation using weight-bearing adiographs one group recieves surgery, one group recieves non-surgical treatment.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Lateral Malleolus Fractures
  • Ankle Fractures
Intervention  ICMJE
  • Procedure: Open reduction internal fixation (ORIF)
    Open fracture reduction followed by internal fixation using a plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.
  • Other: Conservative treatment
    Conservative treatment involves ankle protection with a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.
Study Arms  ICMJE
  • Active Comparator: Weight-bearing stable/Gravity stable
    Ankles that are considered stable using weight-bearing radiographs AND gravity stress test will be assigned to conservative treatment
    Intervention: Other: Conservative treatment
  • Active Comparator: Weight-bearing stable/Gravity unstable
    Ankles that are considered stable using weight-bearing radiographs but unstable using gravity stress test will be assigned to conservative treatment
    Intervention: Other: Conservative treatment
  • Active Comparator: Weight-bearing unstable/Gravity unstable
    Ankles that are considered unstable using weight-bearing radiographs AND gravity stress test will be assigned to open reduction internal fixation (ORIF)
    Intervention: Procedure: Open reduction internal fixation (ORIF)
  • Active Comparator: Weight-bearing unstable/Gravity stable
    Ankles that are considered unstable using weight-bearing radiographs but stable using gravity stress test will be assigned to open reduction internal fixation (ORIF)
    Intervention: Procedure: Open reduction internal fixation (ORIF)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Isolated Weber type B fractures without radiological signs of medial clear space widening on initial radiographs. Patients must be 18-80 years of age. Before the injury patients should be mobilized without walking aids. They should be compliant with good communication skills in the Norwegian or English languages. Patients must live in Østfold or nearby areas so they are able to meet to follow-up consultations.

Exclusion Criteria:

  • Patients presenting with any of the following will be excluded from the study: Fracture of the medial malleolus. Information about prehospital fracture closed reduction. Open fracture. Fracture resulting from high-energy trauma or multi-trauma. Pathologic fracture. Diabetes Mellitus type 1 and 2. Neuropathies. Cognitive disorders. Previous history of ankle fracture. Previous history of ankle-/foot surgery. Generalized joint disease such as RA. Patients with insufficient Norwegian or English language proficiency or lack of communication skills.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Martin Greger Gregersen +4748171718 martingjohansen@gmail.com
Contact: Marius Molund +4790093988 marius.molund@so-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03831009
Other Study ID Numbers  ICMJE 18/07031-7
2018/1585/REK sør-øst B ( Other Grant/Funding Number: Regional Committees for Medical and Health Research Ethics )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ostfold Hospital Trust
Study Sponsor  ICMJE Ostfold Hospital Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marius Molund Østfold Hospital Trust
PRS Account Ostfold Hospital Trust
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP